CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 39 enrolled
Drug / intervention
OROS methylphenidate +1 moredrug
Likely dose
OROS methylphenidate 18 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00593112
NCT00593112Phase 4Completed

A Pilot Study of Proton Magnetic Spectroscopy in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) Before and After Treatment With Osmotic-controlled Release Oral Delivery System (OROS) Methylphenidate

Massachusetts General Hospital·interventional·Posted Jan 14, 2008·Updated Aug 31, 2012

In Brief

A Phase 4 clinical trial evaluating OROS methylphenidate and No intervention for ADHD. Completed, enrolled 39 participants across 1 site.

Detailed Summary

This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS. Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 14, 2008
Enrollment StartNov 1, 2006
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.5 years ago

Interventions

OROS methylphenidatedrug

Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks.

No interventionother

No intervention